ABOUT FORGE

Forge, a member of Ajinomoto Bio-Pharma Services, is a gene therapy development engine, focused on enabling access to life changing gene therapies and helping bring them from idea into reality. We partner with innovators in the gene therapy community: scientists, physicians, biotech/pharma companies, and patient groups. We bring expertise in gene therapy manufacturing and therapeutics development to the table, helping to champion teams that are navigating the long road from the lab bench to the bedside. Our goal is simple but vital to patients living with disease, and we take it seriously. With a patient-first approach, we are forging new models for working together to better accelerate these transformative medicines to reach those who need them the most.
Forge is based in Columbus, Ohio, in a 200,000 square foot facility known affectionately by team members as, the Hearth. The Hearth, is a custom-designed cGMP facility dedicated to AAV manufacturing and hosts scalable, end-to-end manufacturing services.

PREFERRED SKILLS

• Experience supporting FDA and international regulatory inspections.
• Working knowledge of global pharmacopeias (USP, EP, JP, BP, Ph. Eur.).
• Knowledge of biopharmaceutical manufacturing workflows, including sterile injectable pharmaceuticals or biologics.
• Proficiency with Veeva Vault QMS or other electronic quality management systems.
• Technical writing skills for investigations, CAPAs, and regulatory documentation
  This position works in both a laboratory environment and typical office environment where the physical work demands will vary depending on the specific tasks and duties required of the job. The employee will be stationary (standing/sitting) for extended periods of time. Employees regularly wear personal protective equipment based on the task being performed. Must be able to work in a confined space, such as a clean room or laboratory environment. Ability to identify small details within the field of vision, distinguish between different colors, and accurately identify objects within a specific area.
  This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or new ones may be assigned.
  Forge Biologics is an equal opportunity employer dedicated to building an inclusive and diverse workforce. Forge Biologics, provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

ABOUT THE ROLE

The Sr. Quality Systems Specialist provides advanced quality systems expertise and operational support for Forge’s GMP facility in Grove City, OH. This role serves as a subject matter expert (SME) in deviation management, CAPA, change control, and investigations, and drives continuous improvement within the Quality Management System (QMS). The Sr. Specialist partners cross-functionally to ensure quality standards are met, compliance is maintained, and processes are efficient and robust.

WHAT YOU’LL DO

• Serve as a primary SME for quality system processes, including documentation control, change control, deviations, CAPAs, and investigations.
• Lead or review complex investigations, applying in-depth root cause analysis and implementing effective, sustainable CAPAs.
• Review and approve controlled documentation, including Standard Operating Procedures (SOPs), Work Instructions, and Forms.
• Collaborate with technical teams to resolve quality issues, close process gaps, and drive compliant, efficient solutions.
• Identify and lead continuous improvement initiatives to enhance quality and operational efficiency.
• Support internal and external audits and regulatory inspections, providing subject matter expertise as needed.
• Make fact-based, scientifically and/or statistically sound, regulatory-compliant recommendations that may impact product quality decisions.